The Cambridge Handbook of Health Research Regulation PDF Download
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Author: Graeme Laurie
Publisher:
ISBN: 1108576095
Category : Law
Languages : en
Pages : 444
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Book Description
The definitive reference guide to designing scientifically sound and ethically robust medical research, considering legal, ethical and practical issues.
Author: Graeme Laurie
Publisher:
ISBN: 1108576095
Category : Law
Languages : en
Pages : 444
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Book Description
The definitive reference guide to designing scientifically sound and ethically robust medical research, considering legal, ethical and practical issues.
Author: James Leong
Publisher: Springer
ISBN: 3319158058
Category : Medical
Languages : en
Pages : 326
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Book Description
This book proposes and investigates a universal framework, and accompanying documentation system, to facilitate and catalogue benefit-risk decisions; a valuable addition to the benefit-risk toolbox. Over the past decade, pharmaceutical companies and regulatory agencies have been reviewing the benefit-risk assessment of medicines with a view to developing a structured, systematic, standardized approach. Examining the evaluation of such an approach by several mature regulatory authorities ensures that the reader gains a unique insight into the ongoing debate in this area. The field of benefit-risk assessment continues to evolve at a rapid pace due to political and societal pressure, as is reflected in the recent FDA PUDFA agreement as well as in the EMA 2015 Roadmap. Rather than provide a comprehensive snap-shot of this constantly changing environment, this book evaluates selected current approaches to benefit-risk assessment. The strengths and weaknesses of publicly available documents in communicating benefit-risk decisions to stakeholders are reviewed and these evaluations are used to inform development of a prospective framework that could be used to harmonise procedures globally.
Author: Richard Wilson
Publisher: Harvard School of Public Health, Frangois-Xavier Bagnoud Cen
ISBN:
Category : Business & Economics
Languages : en
Pages : 396
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Book Description
Over the centuries, mankind has slowly reduced the risks and hazards that even as recently as a century ago kept life expectancy to a mere 45 years. Our average lifespan has improved to 77 years by remarkable progress in public health and safety. But with this improvement has come a demand for greater efforts to improve both life expectancy and the quality of life. The first edition of this book, published in 1982, was a pioneer in the development of logical, yet simple, analytic tools for discussion of the risks which we all face. This new edition, revised, expanded, and illustrated in detail, should be of value both to professionals in the field and to those who wish to understand these vital issues.
Author: Qi Jiang
Publisher: CRC Press
ISBN: 1482259370
Category : Mathematics
Languages : en
Pages : 296
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Book Description
Guides You on the Development and Implementation of B–R Evaluations Benefit–Risk Assessment Methods in Medical Product Development: Bridging Qualitative and Quantitative Assessments provides general guidance and case studies to aid practitioners in selecting specific benefit–risk (B–R) frameworks and quantitative methods. Leading experts from industry, regulatory agencies, and academia present practical examples, lessons learned, and best practices that illustrate how to conduct structured B–R assessment in clinical development and regulatory submission. The first section of the book discusses the role of B–R assessments in medicine development and regulation, the need for both a common B–R framework and patient input into B–R decisions, and future directions. The second section focuses on legislative and regulatory policy initiatives as well as decisions made at the U.S. FDA’s Center for Devices and Radiological Health. The third section examines key elements of B–R evaluations in a product’s life cycle, such as uncertainty evaluation and quantification, quantifying patient B–R trade-off preferences, ways to identify subgroups with the best B–R profiles, and data sources used to assist B–R assessment. The fourth section equips practitioners with tools to conduct B–R evaluations, including assessment methodologies, a quantitative joint modeling and joint evaluation framework, and several visualization tools. The final section presents a rich collection of case studies. With top specialists sharing their in-depth knowledge, thought-provoking considerations, and practical advice, this book offers comprehensive coverage of B–R evaluation methods, tools, and case studies. It gives practitioners a much-needed toolkit to develop and conduct their own B–R evaluations.
Author: Andreas Sashegyi
Publisher: CRC Press
ISBN: 143986795X
Category : Mathematics
Languages : en
Pages : 216
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Book Description
Many practitioners in the pharmaceutical industry are still largely unfamiliar with benefit-risk assessment, despite its growing prominence in drug development and commercialization. Helping to alleviate this knowledge gap, Benefit-Risk Assessment in Pharmaceutical Research and Development provides a succinct overview of the key considerations rele
Author: Edmund A. C. Crouch
Publisher:
ISBN:
Category : Business & Economics
Languages : en
Pages : 248
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Book Description
Over the centuries, mankind has slowly reduced the risks and hazards that even as recently as a century ago kept life expectancy to a mere 45 years. Our average lifespan has improved to 77 years by remarkable progress in public health and safety. But with this improvement has come a demand for greater efforts to improve both life expectancy and the quality of life. The first edition of this book, published in 1982, was a pioneer in the development of logical, yet simple, analytic tools for discussion of the risks which we all face. This new edition, revised, expanded, and illustrated in detail, should be of value both to professionals in the field and to those who wish to understand these vital issues.
Author: Carla Guerriero
Publisher: Academic Press
ISBN: 0128129360
Category : Business & Economics
Languages : en
Pages : 312
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Book Description
Cost-benefit Analysis of Environmental Health Interventions clearly articulates the core principles and fundamental methodologies underpinning the modern economic assessment of environmental intervention on human health. Taking a practical approach, the book provides a step-by-step approach to assigning a monetary value to the health benefits and disbenefits arising from interventions, using environmental information and epidemiological evidence. It summarizes environmental risk factors and explores how to interpret and understand epidemiological data using concentration-response, exposure-response or dose-response techniques, explaining the environmental interventions available for each environmental risk factor. It evaluates in detail two of the most challenging stages of Cost-Benefit Analysis in 'discounting' and 'accounting for uncertainty'. Further chapters describe how to analyze and critique results, evaluate potential alternatives to Cost-Benefit Analysis, and on how to engage with stakeholders to communicate the results of Cost-Benefit Analysis. The book includes a detailed case study how to conduct a Cost-Benefit Analysis. It is supported by an online website providing solution files and detailing the design of models using Excel. - Provides a clear understanding of the core theory of cost-benefit analysis in environmental health interventions - Provides practical guidance using real-world case studies to motivate and expand understanding - Describes the challenging 'discounting' and 'accounting for uncertainty' problems at chapter length - Supported by a practical case study, online solution files, and a practical guide to the design of CBA models using Excel
Author: Yacov Haimes
Publisher: Springer Science & Business Media
ISBN: 1489921680
Category : Technology & Engineering
Languages : en
Pages : 292
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Book Description
Ronald M. North President Universities Council on Water Resources People sense intuitively that the world in which we live is not free of risk. Every decision, every action, even the refusal to either act or decide involves some element of risk. Perhaps, because we accept relatively low levels of risk in our daily activi ties, we tend to minimize the existence of risk and thereby fail to include risk assessment in those decisions and actions which could be improved through a risk assessment process. However, our casual approach to risk assessment seems to stem largely from the diffi culties inherent in measuring risk rather than from any lack of cognizance of the existence of risk. This conclusion is evidenced by the many statements in official documents relating to planning and evaluation which suggest that risk assessments should be con ducted but do not provide the mechanism for such assessments nor do they encourage their consideration in the decision making process. This conference on Risk/Benefit Analysis in Water Resources Planning and Management is notable because it attempts to identify and evaluate the mechanisms available for risk assessment which might be useful in water resources planning and management efforts. These proceedings bring together the thoughts of professional per sons who have struggled with the problems of risk assessment and who have contributed to the refinement of both theoretical and pragmatic solutions for the improvement of risk assessment processes.
Author: National Research Council
Publisher: National Academies Press
ISBN: 0309367867
Category : Science
Languages : en
Pages : 131
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Book Description
On October 17, 2014, spurred by incidents at U.S. government laboratories that raised serious biosafety concerns, the United States government launched a one-year deliberative process to address the continuing controversy surrounding so-called "gain-of-function" (GOF) research on respiratory pathogens with pandemic potential. The gain of function controversy began in late 2011 with the question of whether to publish the results of two experiments involving H5N1 avian influenza and continued to focus on certain research with highly pathogenic avian influenza over the next three years. The heart of the U.S. process is an evaluation of the potential risks and benefits of certain types of GOF experiments with influenza, SARS, and MERS viruses that would inform the development and adoption of a new U.S. Government policy governing the funding and conduct of GOF research. Potential Risks and Benefits of Gain-of-Function Research is the summary of a two-day public symposia on GOF research. Convened in December 2014 by the Institute of Medicine and the National Research Council, the main focus of this event was to discuss principles important for, and key considerations in, the design of risk and benefit assessments of GOF research. Participants examined the underlying scientific and technical questions that are the source of current discussion and debate over GOF research involving pathogens with pandemic potential. This report is a record of the presentations and discussion of the meeting.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309133386
Category : Medical
Languages : en
Pages : 445
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Book Description
In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies. Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.
